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www.ema.europa.eu EMA has recommended granting a marketing authorisation in the European Union (EU) for Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes in adults and in children from 8 years of age with stage 2 type 1 diabetes. Type 1 diabetes is a chronic autoimmune...
www.ema.europa.eu CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion, in exceptional circumstances, for a marketing authorisation for Vaxxinact H5 (Avian influenza vaccine (subunit recombinant)) intended for the following indications associated with...
www.ema.europa.eu The campaign was developed jointly with the European Consumer Organisation, the European Association of Hospital Pharmacists, European Association of Nuclear Medicine, the European Paediatric Neurology Society , the European Community Pharmacists and the European Union of...
www.ema.europa.eu New safety information for healthcare professionals Injectable tranexamic acid: serious adverse reactions when inadvertently given intrathecally PRAC agreed on a direct healthcare professional communication (DHPC) to remind healthcare professionals that extreme caution...
www.ema.europa.eu At the ICMRA Summit 2025, international medicines authorities addressed the regulators’ role as communicators of reliable, evidence-based, scientific information and the importance of trust and transparency. They highlighted positive examples of reliance pathways saving...
www.ema.europa.eu Partnering with content creators The Agency carefully selected content creators from seven different Member States of the European Union (EU) to ensure a balanced geographical coverage. They were chosen for their credibility in healthcare communication and their alignment...